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1. (2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)acetic Acid
2. Alerlisin
3. Aller-tec
4. Cetalerg
5. Ceterifug
6. Ceti Tad
7. Ceti-puren
8. Cetiderm
9. Cetidura
10. Cetil Von Ct
11. Cetilich
12. Cetirigamma
13. Cetirizin Al
14. Cetirizin Azu
15. Cetirizin Basics
16. Cetirizine
17. Cetirizine Dihydrochloride
18. Cetirlan
19. Dihydrochloride, Cetirizine
20. P 071
21. P-071
22. P071
23. Reactine
24. Virlix
25. Voltric
26. Zetir
27. Zirtek
28. Zyrtec
1. Cetirizine Dihydrochloride
2. 83881-52-1
3. Zyrtec
4. Reactine
5. Cetirizine Dihcl
6. Cetrine
7. 2-(2-(4-((4-chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)acetic Acid Dihydrochloride
8. Alerlisin
9. Cetirizine Hcl
10. Virlix
11. P 071
12. Zirtek
13. P-071
14. Zerviate
15. Cetirizine (dihydrochloride)
16. 2-[2-[4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]acetic Acid;dihydrochloride
17. 83881-52-1 (hcl)
18. 64o047ktoa
19. Nsc-759102
20. Cetirigamma
21. Alercet
22. Alergex
23. Alertisin
24. Cetalerg
25. Ceterifug
26. Cetidura
27. Cetirlan
28. Cetriler
29. Cetzine
30. Formistin
31. Ressital
32. Salvalerg
33. Setiral
34. Stopaler
35. Voltric
36. Zyrzine
37. Alerid
38. Riztec
39. Virdos
40. Zirtin
41. Cezin
42. Ryzen
43. Zetir
44. Cetilich
45. Triz
46. Cetirizin Basics
47. Xero-sed
48. Ceti-puren
49. Cetil Von Ct
50. Cetirizin Azu
51. Children's Zyrtec
52. (2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)acetic Acid Dihydrochloride
53. [2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic Acid Dihydrochloride
54. Dsstox_cid_24268
55. Dsstox_rid_80138
56. Dsstox_gsid_44268
57. Ceti Tad
58. Alleroff
59. Allergy Relief
60. Apo-cetirizine
61. Zyrtec Allergy
62. Zyrtec Hives Relief
63. Cetirizine Hydrochloride [usan]
64. Ucb-p 071
65. Topcare All Day Allergy
66. Sun Mark All Day Allergy
67. Children's Zyrtec Allergy
68. Unii-64o047ktoa
69. Cetirizine Hydrochloride Hives
70. Cetirizine Di
71. Children's Zyrtec Hives Relief
72. Sr-01000688282
73. Cetirizine Hydrochloride Allergy
74. Cetirizine 2hcl
75. Up And Up All Day Allergy Relief
76. Prestwick_841
77. Cetirizine Hydrochloride [usan:usp]
78. Xyzal Dihydrochloride
79. Zyrtec (tn)
80. Quzyttir
81. 774596-22-4
82. Ox-nla
83. Children's Cetirizine Hydrochloride Allergy
84. Ncgc00016949-01
85. Cetirizine-d8 Hydrochloride
86. Cas-83881-52-1
87. Children's Cetirizine Hydrochloride Hives Relief
88. (+-)-(2-(4-(p-chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)acetic Acid, Dihydrochloride
89. Schembl41107
90. Spectrum1505371
91. Chebi:3562
92. Ucb P071
93. Cetirizine Hydrochloride (1:2)
94. Chembl1607273
95. Dtxsid2044268
96. Hms1569f07
97. Hms1922h04
98. Bcp09018
99. Tox21_110704
100. Tox21_302261
101. Tox21_500362
102. Hy-17042a
103. Mfcd00941428
104. S1291
105. Cetirizine Hydrochloride (jp17/usp)
106. Cetirizine Hydrochloride [jan]
107. Akos000280979
108. Akos016340521
109. Tox21_110704_1
110. Ac-1600
111. Ccg-213404
112. Cetirizine Dihydrochloride [mi]
113. Cs-1798
114. Ks-1042
115. Lp00362
116. Nsc 759102
117. Cetirizine Hydrochloride [mart.]
118. Cetirizine Hydrochloride [vandf]
119. Cetirizine Hydrochloride [usp-rs]
120. Cetirizine Hydrochloride [who-dd]
121. Ncgc00095180-01
122. Ncgc00095180-02
123. Ncgc00255965-01
124. Ncgc00261047-01
125. Ncgc00263567-01
126. Acetic Acid, (2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, Dihydrochloride, (+-)-
127. Bc164297
128. Cetirizine Dihydrochloride, >=98% (hplc)
129. Db-056756
130. (r)-cetirizine Dihcl (levocetirizine Dihcl)
131. Ft-0603000
132. Ft-0631130
133. Ft-0664487
134. Sw196972-3
135. Cetirizin Dihydrochloride, >=98.0% (hplc)
136. Cetirizine Hydrochloride [orange Book]
137. Cetirizine Hydrochloride [usp Monograph]
138. D00664
139. F20462
140. Cetirizine Dihydrochloride [ep Monograph]
141. 881c510
142. A840675
143. Zyrtec-d Component Cetirizine Hydrochloride
144. Sr-01000688282-3
145. Cetirizine Hydrochloride Component Of Zyrtec-d
146. Q27263769
147. Cetirizine Dihydrochloride 1.0 Mg/ml In Water (as Free Base)
148. Cetirizine Dihydrochloride, European Pharmacopoeia (ep) Reference Standard
149. Cetirizine Hydrochloride, British Pharmacopoeia (bp) Reference Standard
150. (rs)-{2-[4-(alpha-phenyl-p-chlorobenzyl)-piperazin-1-yl]ethoxy}-acetic Acid Dihydrochloride
151. [2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]aceticaciddihydrochloride
152. 2-(2-(4-((4-chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)acetic Acid 2hcl
153. 2-(2-(4-((4-chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)aceticaciddihydrochloride
154. Cetirizine Dihydrochloride, United States Pharmacopeia (usp) Reference Standard
155. Cetirizine For Peak Identification, European Pharmacopoeia (ep) Reference Standard
156. Cetirizine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
157. (+) {2-[4-(alpha-phenyl-p-chlorobenzyl)-piperazine-1-yl] -ethoxy}-acetic Acid Dihydrochloride
158. (+/-)-(2-(4-(p-chloro-a-phenylbenzyl)-1-piperazinyl)ethoxy)acetic Acid, Dihydrochloride
159. (+/-){2-[4-(alpha-phenyl-p-chlorobenzyl)-piperazin-1-yl]-ethoxy}-acetic Acid Dihydrochloride
160. (rs)-{2-[4-(alpha-phenyl-p-chlorobenzyl)-piperazin-1-yl]ethoxy }-acetic Acid Dihydrochloride
161. 2-(2-(4-(p-chloro-alpha-phenylbenzyl)1-piperazinyl)ethoxy) Acetic Acid Dihydrochloride
162. 2-(2-{4-[(4-chlorophenyl)(phenyl)-methyl]piperazino}ethoxy)acetic Acid Dihydrochloride;cetirizine Dihydrochloride
163. Acetic Acid, (2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, Dihydrochloride, (+/-)-
164. Acetic Acid, 2-[2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]-, Hydrochloride (1:2)
165. Cetirizine Dihydrochloride Solution, 1.0 Mg/ml In Acetonitrile: Water (9:1) (as Free Base), Ampule Of 1 Ml, Certified Reference Material
1. Cetirizin Dihydrochloride
2. Cetirizine Hcl
| Molecular Weight | 461.8 g/mol |
|---|---|
| Molecular Formula | C21H27Cl3N2O3 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 8 |
| Exact Mass | 460.108726 g/mol |
| Monoisotopic Mass | 460.108726 g/mol |
| Topological Polar Surface Area | 53 Ų |
| Heavy Atom Count | 29 |
| Formal Charge | 0 |
| Complexity | 443 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 3 |
| 1 of 20 | |
|---|---|
| Drug Name | Cetirizine hydrochloride |
| Drug Label | Cetirizine hydrochloride is an orally active and selective H1-receptor antagonist. The chemical name is () - [2- [4- [ (4-chlorophenyl) phenylmethyl]- 1 - piperazinyl] ethoxy] acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic comp... |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Prescription |
| Company | Perrigo R And D; Amneal Pharms; Wockhardt; Silarx; Teva Pharms; Caraco; Breckenridge Pharm; Bio Pharm; Vintage; Taro |
| 2 of 20 | |
|---|---|
| Drug Name | Cetirizine hydrochloride allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet; Capsule; Tablet, chewable |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Wockhardt; Ranbaxy; Amneal Pharms Ny; Ipca Labs; Unichem; Apotex; Contract Pharmacal; Sun Pharm Inds; Taro; Torrent Pharms; Cadista Pharms; Dr Reddys Labs; Sandoz; Unique Pharm Labs; Banner Pharmacaps; Cipla; Orchid Hlthcare; Mylan |
| 3 of 20 | |
|---|---|
| Drug Name | Cetirizine hydrochloride hives |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Ranbaxy; Ipca Labs; Unichem; Sun Pharm Inds; Cadista Pharms; Dr Reddys Labs; Unique Pharm Labs; Orchid Hlthcare; Mylan |
| 4 of 20 | |
|---|---|
| Drug Name | Children's cetirizine hydrochloride allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup; Tablet, chewable |
| Route | Oral |
| Strength | 5mg; 10mg; 5mg/5ml |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Amneal Pharms; Silarx; Cypress Pharm; Caraco; Bio Pharm; Aurobindo Pharma; Taro; Sun Pharma Global; Tris Pharma |
| 5 of 20 | |
|---|---|
| Drug Name | Children's cetirizine hydrochloride hives relief |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup; Tablet, chewable |
| Route | Oral |
| Strength | 5mg; 10mg; 5mg/5ml |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Amneal Pharms; Silarx; Cypress Pharm; Caraco; Bio Pharm; Aurobindo Pharma; Taro; Sun Pharma Global; Tris Pharma |
| 6 of 20 | |
|---|---|
| Drug Name | Children's zyrtec allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
| 7 of 20 | |
|---|---|
| Drug Name | Children's zyrtec hives relief |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
| 8 of 20 | |
|---|---|
| Drug Name | Zyrtec |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Prescription |
| Company | Mcneil Consumer |
| 9 of 20 | |
|---|---|
| Drug Name | Zyrtec allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet; Tablet, orally disintegrating |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
| 10 of 20 | |
|---|---|
| Drug Name | Zyrtec hives relief |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
| 11 of 20 | |
|---|---|
| Drug Name | Cetirizine hydrochloride |
| Drug Label | Cetirizine hydrochloride is an orally active and selective H1-receptor antagonist. The chemical name is () - [2- [4- [ (4-chlorophenyl) phenylmethyl]- 1 - piperazinyl] ethoxy] acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic comp... |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Prescription |
| Company | Perrigo R And D; Amneal Pharms; Wockhardt; Silarx; Teva Pharms; Caraco; Breckenridge Pharm; Bio Pharm; Vintage; Taro |
| 12 of 20 | |
|---|---|
| Drug Name | Cetirizine hydrochloride allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet; Capsule; Tablet, chewable |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Wockhardt; Ranbaxy; Amneal Pharms Ny; Ipca Labs; Unichem; Apotex; Contract Pharmacal; Sun Pharm Inds; Taro; Torrent Pharms; Cadista Pharms; Dr Reddys Labs; Sandoz; Unique Pharm Labs; Banner Pharmacaps; Cipla; Orchid Hlthcare; Mylan |
| 13 of 20 | |
|---|---|
| Drug Name | Cetirizine hydrochloride hives |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Ranbaxy; Ipca Labs; Unichem; Sun Pharm Inds; Cadista Pharms; Dr Reddys Labs; Unique Pharm Labs; Orchid Hlthcare; Mylan |
| 14 of 20 | |
|---|---|
| Drug Name | Children's cetirizine hydrochloride allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup; Tablet, chewable |
| Route | Oral |
| Strength | 5mg; 10mg; 5mg/5ml |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Amneal Pharms; Silarx; Cypress Pharm; Caraco; Bio Pharm; Aurobindo Pharma; Taro; Sun Pharma Global; Tris Pharma |
| 15 of 20 | |
|---|---|
| Drug Name | Children's cetirizine hydrochloride hives relief |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup; Tablet, chewable |
| Route | Oral |
| Strength | 5mg; 10mg; 5mg/5ml |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Amneal Pharms; Silarx; Cypress Pharm; Caraco; Bio Pharm; Aurobindo Pharma; Taro; Sun Pharma Global; Tris Pharma |
| 16 of 20 | |
|---|---|
| Drug Name | Children's zyrtec allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
| 17 of 20 | |
|---|---|
| Drug Name | Children's zyrtec hives relief |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
| 18 of 20 | |
|---|---|
| Drug Name | Zyrtec |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Prescription |
| Company | Mcneil Consumer |
| 19 of 20 | |
|---|---|
| Drug Name | Zyrtec allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet; Tablet, orally disintegrating |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
| 20 of 20 | |
|---|---|
| Drug Name | Zyrtec hives relief |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
Histamine H1 Antagonists, Non-Sedating
A class of non-sedating drugs that bind to but do not activate histamine receptors (DRUG INVERSE AGONISM), thereby blocking the actions of histamine or histamine agonists. These antihistamines represent a heterogenous group of compounds with differing chemical structures, adverse effects, distribution, and metabolism. Compared to the early (first generation) antihistamines, these non-sedating antihistamines have greater receptor specificity, lower penetration of BLOOD-BRAIN BARRIER, and are less likely to cause drowsiness or psychomotor impairment. (See all compounds classified as Histamine H1 Antagonists, Non-Sedating.)
Anti-Allergic Agents
Agents that are used to treat allergic reactions. Most of these drugs act by preventing the release of inflammatory mediators or inhibiting the actions of released mediators on their target cells. (From AMA Drug Evaluations Annual, 1994, p475) (See all compounds classified as Anti-Allergic Agents.)
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RLD : No
TE Code :
Brand Name : CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Approval Date : 2017-12-22
Application Number : 209274
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form : SOLUTION;ORAL
Dosage Strength : 5MG/5ML
Approval Date : 2008-05-09
Application Number : 90378
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Approval Date : 2007-12-28
Application Number : 78427
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : ZERVIATE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : EQ 0.24% BASE
Approval Date : 2017-05-30
Application Number : 208694
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form : TABLET, CHEWABLE;ORAL
Dosage Strength : 10MG
Approval Date : 2008-02-14
Application Number : 78692
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Approval Date : 2007-12-27
Application Number : 77498
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form : TABLET, CHEWABLE;ORAL
Dosage Strength : 5MG
Approval Date : 2008-01-11
Application Number : 77631
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Dosage Form : TABLET, CHEWABLE;ORAL
Dosage Strength : 10MG
Approval Date : 2011-08-30
Application Number : 90142
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
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DOSAGE - SOLUTION;ORAL - 5MG/5ML
USFDA APPLICATION NUMBER - 22155
DOSAGE - CAPSULE;ORAL - 10MG
USFDA APPLICATION NUMBER - 22429
DOSAGE - CAPSULE;ORAL - 5MG
USFDA APPLICATION NUMBER - 22429
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PharmaCompass offers a list of Cetirizine Dihydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Cetirizine Dihydrochloride manufacturer or Cetirizine Dihydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cetirizine Dihydrochloride manufacturer or Cetirizine Dihydrochloride supplier.
PharmaCompass also assists you with knowing the Cetirizine Dihydrochloride API Price utilized in the formulation of products. Cetirizine Dihydrochloride API Price is not always fixed or binding as the Cetirizine Dihydrochloride Price is obtained through a variety of data sources. The Cetirizine Dihydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Alercet manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alercet, including repackagers and relabelers. The FDA regulates Alercet manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alercet API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Alercet manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alercet supplier is an individual or a company that provides Alercet active pharmaceutical ingredient (API) or Alercet finished formulations upon request. The Alercet suppliers may include Alercet API manufacturers, exporters, distributors and traders.
click here to find a list of Alercet suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alercet DMF (Drug Master File) is a document detailing the whole manufacturing process of Alercet active pharmaceutical ingredient (API) in detail. Different forms of Alercet DMFs exist exist since differing nations have different regulations, such as Alercet USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alercet DMF submitted to regulatory agencies in the US is known as a USDMF. Alercet USDMF includes data on Alercet's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alercet USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alercet suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Alercet Drug Master File in Japan (Alercet JDMF) empowers Alercet API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Alercet JDMF during the approval evaluation for pharmaceutical products. At the time of Alercet JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Alercet suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Alercet Drug Master File in Korea (Alercet KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Alercet. The MFDS reviews the Alercet KDMF as part of the drug registration process and uses the information provided in the Alercet KDMF to evaluate the safety and efficacy of the drug.
After submitting a Alercet KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Alercet API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Alercet suppliers with KDMF on PharmaCompass.
A Alercet CEP of the European Pharmacopoeia monograph is often referred to as a Alercet Certificate of Suitability (COS). The purpose of a Alercet CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Alercet EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Alercet to their clients by showing that a Alercet CEP has been issued for it. The manufacturer submits a Alercet CEP (COS) as part of the market authorization procedure, and it takes on the role of a Alercet CEP holder for the record. Additionally, the data presented in the Alercet CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Alercet DMF.
A Alercet CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Alercet CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Alercet suppliers with CEP (COS) on PharmaCompass.
A Alercet written confirmation (Alercet WC) is an official document issued by a regulatory agency to a Alercet manufacturer, verifying that the manufacturing facility of a Alercet active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Alercet APIs or Alercet finished pharmaceutical products to another nation, regulatory agencies frequently require a Alercet WC (written confirmation) as part of the regulatory process.
click here to find a list of Alercet suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Alercet as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Alercet API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Alercet as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Alercet and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Alercet NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Alercet suppliers with NDC on PharmaCompass.
Alercet Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Alercet GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Alercet GMP manufacturer or Alercet GMP API supplier for your needs.
A Alercet CoA (Certificate of Analysis) is a formal document that attests to Alercet's compliance with Alercet specifications and serves as a tool for batch-level quality control.
Alercet CoA mostly includes findings from lab analyses of a specific batch. For each Alercet CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Alercet may be tested according to a variety of international standards, such as European Pharmacopoeia (Alercet EP), Alercet JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alercet USP).
